February 9, 2007 - See Notice (NOT-MH-07-105) The purpose of this notice is to add NCI Scientific/Research and Financial/Grants Management contact information.

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.

Purpose.The purpose of this Funding Opportunity Announcement (FOA) is to solicit grant applications to expand basic and translational research on the processes and mechanisms involved in the experience, expression, and regulation of emotion.

Mechanism of Support. This FOA will utilize the NIH Research Project Grant (R01) award mechanism.Applications of related or identical scientific scope are solicited also under the Small Research Grant (R03) and the Exploratory/Developmental Grant (R21) award mechanisms, responding to FOAs PA-06-180 and PA-06-181, respectively

Funds Available and Anticipated Number of Awards. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. The total amount awarded and the number of awards will depend upon the mechanism numbers, quality, duration, and costs of the applications received.

Eligible Project Directors/Principal Investigators (PDs/PIs).Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

Number of Applications. Applicants may submit more than one application, provided each application is scientifically distinct.

Renewals and Resubmissions. Applications can be renewed by competing for additional project periods.Applicants may submit a “resubmission” application, but such application must include an “Introduction” (3 pages maximum) addressing the previous peer review critique (Summary Statement).

Number of PDs/PIs. More than one PD/PI, or multiple PDs/PIs, may be designated on the application.

Under this Funding Opportunity Announcement (FOA), the National Institute of Mental Health (NIMH), the National Institute on Aging (NIA), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), the National Cancer Institute (NCI), the National Institute of Child Health and Human Development (NICHD), the National Institute on Drug Abuse (NIDA), and the National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), invite research grant applications to expand basic and translational research on the processes and mechanisms involved in the experience, expression, and regulation of emotion.

The purpose of this FOA is to advance the study of emotion across a broad range of areas outlined below. The study of emotion encompasses a wide range of physiological, psychological, social, cognitive, and developmental phenomena. Central and peripheral nervous system (CNS, PNS) activity in the origins, expression, regulation and modulation of emotion are important objects of study, as is the contribution of emotional and motivational systems to cognitive faculties such as perception, attention, learning, memory, and motor control. The study of emotion includes investigations of overt behaviors (such as aggression or withdrawal), interpersonal relationships, communication and decision making, and the environmental circumstances and experiences that shape and elicit emotions. Emotion research can also include the study of licit and illicit psychoactive substances that alter mood states, and conversely, the study of how emotional and mood states can predispose to, or modulate the effects of, pain or alcohol and psychoactive substances. This FOA also encourages research on emotional reactions in the context of the diagnosis and treatment of cancer, and the study of emotion as it relates to this disease or increased risk of this disease, including outcomes such as social relationships, health care provider relationships, adherence and others. These investigations may utilize human or animal subjects.

Recent years have shown the rapid expansion of concepts and methods for studying emotion in all of its aspects. Outlined in this FOA are current needs that stem from these advances and that constitute critical components of a comprehensive basic research strategy, with the ultimate aim of fostering mental and physical health and the understanding of human development and aging. Sample research questions are provided for illustration; they are not intended to be exhaustive.

Basic Mechanisms of Emotion

The study of emotion may involve measurements in a number of different response systems (e.g., neural, physiological, behavioral). To foster the rapid and orderly accumulation of knowledge, it is important that multiple system measurements be conducted whenever possible. Interactions of emotion with cognition also constitute an important area of study. For example, a more detailed understanding is needed of the interplay between emotion and cognition that can inform conceptualizations of disorders in which impairments of both emotion and cognition are apparent (e.g., schizophrenia, depression, alcohol and drug dependence, Alzheimer's disease, autism), as well as provide data important for promoting good cognitive functioning and emotional self-regulation. In addition, the interplay between emotion and cognition may be studied in the context of risk perception, reward processing, preference formation, and decision-making, for example, as this interplay applies to treatment and screening among cancer patients or individuals at increased risk of cancer, drug abuse and other health risking behaviors (e.g., interpersonal violence or sexual risk-taking), and in the context of financial and health care decision-making by older adults. Sample research questions include the following:

What are the relations among behavioral, physiological, and neural aspects of emotion? What are the circumstances under which these various systems act in concert, and what is the significance of various patterns of desynchrony? What is the developmental time course of these components? What are the biological or psychological consequences of the inhibition of one or more components?

A number of different emotion theories posit some number of discrete emotions. Other theories approach the domain as two, three or more dimensions of emotional response. How are these two approaches related, and can they be reconciled in a comprehensive theory of emotion?

What are the basic mechanisms by which emotions are acquired or otherwise shaped by the physiological and social contexts in which they occur? What are the roles of parents, peers, siblings, teachers, care providers, and the media in socializing emotion? How do these socialization processes interact with physiological and neural aspects of emotion?

What are the continuities across, and distinctions among, the phenomena of emotion, mood, temperament, emotional trait, and emotional disorder? What social, psychological, environmental, and biological factors mediate or modulate their interrelationships? How do these interrelationships change with age? How do these phenomena interact in order to contribute to psychological adjustment, normal psychological and biological development, psychopathology, treatment and screening adherence, and quality of life among individuals with physical or mental illness or those at risk for illness?

What are the potential mechanisms by which sensation and perception interact with emotion; and how do these interactions result in behavior? In turn, how are interactions between sensation, perception, and emotion modulated in the experience of pain, in learning and memory, and in cognitive and social development?

How do cognitive and perceptual processes such as attention, memory and perceived threat act to sustain or interrupt emotional states? In turn, how do emotions serve to modulate or drive mechanisms of cognition and perception?

The study of emotional processes in disorders is similar in some aspects to research on basic mechanisms of emotion, and different in other aspects. Impairments of emotion found in psychopathology and developmental disorders may differ in either qualitative or quantitative ways from normal emotional processes. Emotional reactions may interact with disease processes to alter the course of the disorder and these influences may be subject to modification by alcohol or drugs of abuse. Examples of relevant issues include the following:

What are the continuities and discontinuities between normative emotional processes (e.g., emotional development, expression, understanding, awareness, communication, resilience) and emotional processes seen in psychopathology, developmental disorders, neurodegeneration, health risk behaviors including alcohol or drug abuse, or other developmental problems (e.g., insecure attachment, aggressive behaviors, extreme shyness, or difficulties in social relationships)? Are there sex and/or gender differences in the continuity/discontinuity of these processes?

To what extent can behavioral, physiological, and neural measures of emotion identify individuals at risk for suicidal, violent, or self-injurious behavior, or alcohol/drug abuse, in treatment settings or within the context of preventive interventions?

Do individual differences in emotional reactivity and regulation, including responses to stress or trauma, produce differential vulnerabilities to mental or developmental disorders, including alcohol and/or drug dependence, or to chronic illnesses of middle- and older age? Conversely, does alcohol/drug use or dependence produce changes in emotional reactivity? How do stimuli associated with alcohol or drug use become triggers of emotional and subjective states that may lead to relapse?

What role does emotion play in stress diathesis models of the etiology of mental disorders?

What role does physiological reactivity and anxiety play in the experience and expression of emotion?

Among cancer patients or people at increased risk for cancer, how do individual differences in emotional processes relate to fatigue, resumption of activities of daily living, adherence to treatment, cancer screening behaviors, family relationships, and patient-health care provider relationships? What is the role of emotional processes in decision making related to cancer prevention, detection or treatment? Do individual differences in emotional reactivity associated with neural, immunological, or other biological pathways influence cancer?

How can individuals be trained to best identify and regulate emotions and mood states that may represent a possible risk for relapse of physical or mental illness? Does focusing on such emotions/moods help prevent relapse, or actually increase risk for relapse?

How do cognitive, motivational, and neurobiological changes associated with aging modify the experience, expression, and regulation of emotion and its underlying processes in older individuals?

What risk factors, including lifestyle factors, contribute to late-life emotional dysfunction and how can the dysfunction be prevented?

What role does emotion play in helping us to define impairment and functioning across different disorders (e.g., ADHD, anxiety disorders, etc).

What neural circuits underlie comorbid neurological and emotional disorders? Does emotional dysregulation lead to an increase in risk for, or severity of, a given neurodegenerative disease? If so, by what mechanism? What biological markers identify patients with neurological disorders who are at high risk for developing significant depression, anxiety, or mania?

Individual Differences

Research is suggesting that individual differences in emotional responsivity may mark specific vulnerabilities to mental disorder, including alcohol or drug dependence. A detailed examination of these individual differences is critical for understanding the etiology of various disorders and for designing prevention efforts. In-depth study is needed of the determinants, consequences, and sequelae of infant temperament. Research in adult personality variation also is beginning to examine individual differences in emotional responsivity, with some indications of connections to physiology. Sample research questions include the following:

What are the biological (including genetic) and experiential sources of individual differences in emotional reactivity and regulation throughout development? How do biological and experiential factors combine and interact in influencing outcomes? How do these change with age?

What are the factors that shape emotional processes, especially with respect to improvements in emotional functions involved in decision-making, adaptation to changes in health status, or management of social relationships by older adults?

How do individual differences in emotionality relate to phenomena such as activity level, attention, and cognitive processes? What are the neural substrates of the relationships among such phenomena, and how are these relationships maintained or changed over time?

Among children with developmental and learning problems or disabilities or childhood illness, how are individual differences in emotional processes related to functioning over time? What developmental and/or learning disabilities or other pediatric problems interact with the development of emotional regulation and reactivity over time? New approaches that integrate quantitative and qualitative methods are needed to investigate the study of emotion and learning/learning disabilities in order to study these interactions

What are the specific emotional and behavioral differences in individuals with mental retardation and how do these differ from the general population? New techniques are needed to assess the impact of psychosocial stressors in the lives of people with mental retardation and developmental disabilities and to integrate this knowledge with diagnostic protocols, treatment strategies and service systems.

How do emotions get attached to attitudes, stereotypes, and identity? How do these influence health, illness, adherence to medical regimens, and recovery?

Developmental Aspects

Data are accumulating rapidly in areas such as children's understanding and experience of emotions, and in emotional communications occurring between parents and children beginning in the earliest weeks of life. The import of findings related to the development of emotions would be well served by an overarching theoretical framework specifying the ontogeny of emotion. Also, the primary concentration to date on the early years of life needs to be broadened to include focused attention on early and middle childhood, adolescence, adulthood, and old age. Sample research questions include the following:

Are connections among the various components of emotions present at birth? Do these change with age, particularly during periods of transition (e.g., the transition to school, adolescence)? If so, how are these changes expressed? How do changes in bodily systems with age affect the nature and intensity of emotional responses and the interrelationships among these response systems? Do some changes predispose toward psychopathology or drug abuse in older individuals?

What are the determinants, age-specific characteristics, and consequences of emotional attachments across the lifespan? What are the parallels among attachment patterns in infancy, in childhood, in adolescence, in adulthood, in old age?

How do cognitive factors (e.g., intelligence, learning disabilities) influence the development of emotional processes over the lifespan?

What affective processes are particularly germane to coping with events in the family life cycle (e.g., marriage, divorce, birth, transition to parenthood, aging, retirement, grandparenting, dealing with death and bereavement, coping with substance use of family members)?

What are the developmental psychobiological contributions of stress and other environmental influences (e.g., trauma, violence) on emotional development, regulation, and expression?

What is the role of emotion in brain development over the life course and what are the relevant mechanisms? How might emotions affect the endocrine, immune and neural systems that change over the course of development and aging? Does prenatal exposure to alcohol or abused drugs or use of abused drugs in adolescence affect emotional development? Conversely, are children with disorders of emotional regulation more vulnerable to becoming drug dependent? Does sleep deprivation affect emotion regulation, and if so, how?

Social Aspects

The quality of interpersonal relationships can be a significant source of both positive and negative emotions. Further, social relationships play a substantial role in the modulation of emotional responses, however generated. Social factors thus make a critical contribution to an understanding of the risks for mental disorders, alcohol/drug dependence, and other developmental problems. In addition to the need for further research on these interpersonal aspects of emotion, it is very important to examine the macro-environmental processes (e.g., culture, social structure, the media) that help to shape emotional development and adjustment. Sample research questions include the following:

How do cultural and socialization processes influence the experience and expression of emotion? How do salient social factors and contexts (e.g., child care and school settings, media, exposure to violence) in particular developmental stages shape affective development and expression?

What are the dynamics of emotional communications occurring within families and other intimate groups and how do they relate to the development, maintenance, or erosion of emotional bonds? How do variations in social sharing of emotions lead to differences in psychopathology, therapeutic approaches, and potential health outcomes? How can these variables be best modeled preclinically? How are these patterns altered by drug dependence? Among cancer patients and their significant others, what are the short- and long-term consequences of patterns of emotional communication on social relationships and psychological adjustment?

How do variations in parenting style and behaviors (e.g., teaching, limit-setting) influence the development of affect regulation in children? How does child abuse or neglect (resulting from psychopathology, alcohol or drug addiction or other causes) influence emotional development in children?

How does caregiver behavior influence affect regulation in persons with mental disorders or drug abuse in late life, including Alzheimer's disease? Conversely, how do changes in emotional behavior and expression associated with neurodegenerative disorders of late life impact emotional reactivity and regulation in dementia caregivers and family members?

How do the emotions involved with social relationships affect life in the community for severely disordered or disabled individuals, and how do these emotions interact with the characteristics of the disorder to affect its course?

What role does the process of social comparison play in the emotional response to cancer and to aging, what are some potential mechanisms explaining the direction of the social comparison process across individuals, and how might these processes be influenced by other social or non-social mechanisms?

Biological Aspects

The study of emotion provides a valuable opportunity for examination of the interplay between psychological, physiological, and neural processes, and methods are increasingly becoming available for examining the neural substrates of emotion. Sample research questions include the following:

What are the bi-directional influences between emotional states or emotional traits (e.g., temperament) and neurobiological, endocrine and immune systems? Among cancer patients, how might these influences on biology influence health status or treatment (side effects, ability to tolerate treatment)?

What insights into emotional processes can be gained through genetic approaches?

What are the neuroanatomical circuits and neurochemical processes involved in emotional states and emotion-based individual differences? Do these circuits and processes overlap with cognitive circuits and processes; what are the commonalities? How do these systems evolve over the lifespan and how are they influenced by drugs of abuse? To what extent do these neural processes overlap with those associated with psychopathology and substance use disorders such as alcohol or drug addiction?

How can neuroimaging and large-array electrophysiological techniques best be used to study brain areas that are active during different emotional states and in pain perception? What is the relationship of observed CNS or PNS activity to other responses in emotion, including alcohol/drug-induced or alcohol/drug withdrawal- or craving-induced changes in emotion?

How does the aging process, either in association with normal healthy aging or age-associated neurodegenerative disease processes, affect the emotion-based networks within the brain and those that interact with the endocrine system?

Methodological Needs

Methods related to the study of emotion run the full range, from self-report and interview procedures, to behavioral observations and more direct assessments of behavior, and to measures of PNS and CNS structure and function. Improvements are needed in ways that enhance the validity and efficiency of measurement without sacrificing richness and detail. In research on physical illness such as cancer, methodology also is needed that takes into account the reports of others in the patient's social and medical environment, and reports that are sensitive to the changes in emotional responsiveness over time. Sample needs include the following:

Most research on emotional expression concentrates on the face. Methods also are needed to assess vocal, postural, and gestural components of emotional expression. Further, measures of emotion need to be developed that can be applied across settings, cultures, cohorts, and species.

Techniques of computer science, neural networks, and image processing need to be applied to the task of producing valid and reliable judgments of facial and other behavioral expressions of emotion.

Computational models and other quantitative expressions of theories of emotions need to be developed.

Expanded and improved neuroimaging techniques are needed to examine CNS activity in emotional responding. Further research is needed on the methodological and conceptual relationships among techniques with different spatial and temporal resolution.

Animal models need to be used to their fullest potential to examine social, cognitive, and biological determinants and consequences of emotion.

Advanced and ethically-guided human laboratory procedures for inducing positive and negative emotional states are needed.

Determination of new ways to assess positive emotional functions such as mastery, resilience, and self-efficacy are needed.

Specifically, if you are a U.S. organization and are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 5.4, “Modular Budget Component,” of the Application Guide).

U.S. applicants requesting more than $250,000 in annual direct costs and all foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096, August 23, 2006.

2. Funds Available

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the Institutes and Centers (ICs) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

NIH grants policies as described in the NOT-OD-05-004, November 2, 2004.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit an application(s) if your institution/organization has any of the following characteristics:

Indian/Native American Tribal Government (Other than Federally Recognized)

Indian/Native American Tribally Designated Organization

Non-domestic (non-U.S.) Entity (Foreign Organization)

Hispanic-serving Institution

Historically Black Colleges and Universities (HBCUs)

Tribally Controlled Colleges and Universities (TCCUs)

Alaska Native and Native Hawaiian Serving Institutions

Regional Organization

Other(s): Eligible agencies of the Federal government; Faith-based or community based organizations.

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a “team science” approach that clearly does not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available athttps://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (seehttp://era.nih.gov/ElectronicReceipt/preparing.htmfor instructions).

The decision of whether to apply for a single PD/PI or multiple PD/PI grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for multiple PD/PI grants will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PD/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please seehttps://grants.nih.gov/grants/multi_pi.

The individual(s) designated as PDs/PIs on the application must also be registered in the NIH eRA Commons. In the case of multiple PDs/PIs, all PDs/PIs must be registered and be assigned the PI role in the eRA Commons prior to the submission of the application.

Each PD/PI must hold a PD/PI account in the Commons. Applicants should not share a Commons account for both an Authorized Organization Representative/Signing Official (AOR/SO) role and a PD/PI role; however, if they have both a PD/PI role and an Internet Assisted Review (IAR) role, both roles should exist under one Commons account.

When multiple PDs/PIs are proposed, all PDs/PIs at the applicant organization must be affiliated with that organization. PDs/PIs located at another institution need not be affiliated with the applicant organization, but must be affiliated with their own organization to be able to access the Commons.

This registration/affiliation must be done by the AOR/SO or their designee who is already registered in the Commons.

Both the PD/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLYincludes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:

Format: Every effort should be made to comply with the format specifications, which are based upon a standard U.S. paper size of 8.5” x 11” within each PDF.

Funds for up to 8% administrative costs (excluding equipment) may be requested. SeeNOT-OD-01-028, March 29, 2001.

Organizations must comply with Federal/NIH policies on human subjects, animals, and biohazards.

Organizations must comply with Federal/NIH biosafety and biosecurity regulations. See Section VI.2., “Administrative and National Policy Requirements.”

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs

When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact” PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.

Information for the Contact PD/PI should be entered in item 15 of the SF424(R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of “PD/PI.” Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the “Credential” field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership of the project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled “Multiple PD/PI Leadership Plan” (Section 14 of the Research Plan Component in the SF424 (R&R)), must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, including communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.

Applications Involving a Single Institution

When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.

Applications Involving Multiple Institutions

When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.

When submitting a modular budget, the prime institution completes the PHS398 Modular Budget component only. Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are not required when using the Modular budget format. See Section 5.4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component.

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt date(s) and time, the application may be delayed in the review process or not reviewed.

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.

If everything is acceptable, no further action is necessary. The application will automatically move forward for processing by the Division of Receipt and Referral, Center for Scientific Review, NIH, after two business days.

Prior to the submission deadline, the AOR/SO can “Reject” the assembled application and submit a changed/corrected application within the two-day viewing window. This option should be used if the AOR/SO determines that warnings should be addressed or if information was lost or compromised during transmission. Reminder: warnings do not stop further application processing. If an application submission results in warnings (but no errors), it will automatically move forward after two business days if no action is taken. Please remember that some warnings may not be applicable or may need to be addressed after application submission.

If the two-day window falls after the submission deadline, the AOR/SO will have the option to “Reject” the application if, due to an eRA Commons or Grants.gov system issue, the application does not correctly reflect the submitted application package (e.g., some part of the application was lost or didn’t transfer correctly during the submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course of action. NIH will not penalize the applicant for an eRA Commons or Grants.gov system issue.

If the AOR/SO chooses to “Reject” the image after the submission deadline for a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected application still can be submitted, but it will be subject to the NIH late policy guidelines and may not be accepted. The reason for this delay should be explained in the cover letter attachment.

Both the AOR/SO and PD/PI will receive e-mail notifications when the application is rejected or the application automatically moves forward in the process after two days.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR receives the Grants.gov acknowledgments. The AOR and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.

The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an “Introduction” (3 pages maximum) addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 (R&R).

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing renewal (formerly “competing continuation”) award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing renewal award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See the NIH Grants Policy Statement.

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

PHS398 Research Plan Component Sections

Items 2-5 of the PHS398 Research Plan component are limited to 25 pages. While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:

Special Instructions for Modular Grant applications

R01 applications from U.S. institutions/organizations requesting up to $250,000 per year in direct costs (excluding consortium F&A costs) must be submitted in a modular budget format. Additional information on modular budgets is available at https://grants.nih.gov/grants/funding/modular/modular.htm. When submitting a modular budget, the applicant organization will include only the PHS398 Modular Budget component. See Section 5.4 of the SF424 (R&R) Application Guide for further instructions regarding the use of the PHS398 Modular Budget component.

Foreign organizations may not submit modular budgets. See NOT-OD-06-096.

Special Instructions for Applications Requesting $500,000 (direct costs) or More Per Year

Applicants requesting $500,000 or more in direct costs for any year (excluding consortium F&A costs) must carry out the following steps:

1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study;

2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and,

3) Include the PHS398 Cover Letter component with the application to identify the staff member and IC who agreed to accept assignment of the application.

IMPORTANT NOTE: NIH has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review.

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.

Note: While each section of the PHS398 Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to monitor better formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

Foreign Applications (Non-domestic (non-U.S.) Entity)

Indicate how the proposed project has specific relevance to the mission and objectives of the IC and has the potential for significantly advancing the health sciences in the United States.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal Web site, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a plan for sharing research data in their application. The funding organization will be responsible for monitoring the data sharing policy (https://grants.nih.gov/grants/policy/data_sharing).

The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statementhttps://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600131). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590). See Section VI.3., “Reporting.”

Section V. Application Review Information

1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications submitted for this funding opportunity will be assigned to the ICs on the basis of established PHS referral guidelines.

Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score.

Receive a written critique.

Receive a second level of review by the appropriate national advisory council or board.

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

Scientific merit of the proposed project as determined by peer review.

Availability of funds.

Relevance of program priorities.

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.

Significance

Approach

Innovation

Investigator

Environment

Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well-integrated, well-reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? For applications designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs??

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches or methodologies, tools, or technologies for this area?

Investigators: Are the PD/PIs and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level(s) of the principal investigator(s) and other researchers? Do the PD/PIs and investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Do(es) the scientific environment(s) in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment(s), or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

2.A. Additional Review Criteria

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See the “Human Subjects Sections” of the PHS398 Research Plan component of the SF424 (R&R).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. See the “Human Subjects Sections” of the PHS398 Research Plan component of the SF424 (R&R).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the adequacy of the plans for their care and use will be assessed. See the “Other Research Plan Sections” of the PHS398 Research Plan component of the SF424 (R&R).

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget and Period of Support: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research may be assessed by the reviewers. The priority score should not be affected by the evaluation of the budget.

Applications from Foreign Organizations: Does the project present special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources will be assessed.

Resubmission Applications (formerly “revised/amended” applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy. https://grants.nih.gov/grants/policy/data_sharing.

2.D. Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statementhttps://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600131). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590), See Section VI.3., “Reporting.”

Model Organism Sharing Plan: Reviewersare asked to assess the sharing plan in an administrative note. The sharing plan itself should be discussed after the application is scored. Whether a sharing plan is reasonable can be determined by the reviewers on a case-by-case basis, taking into consideration the organism, the timeline, the applicant's decision to distribute the resource or deposit it in a repository, and other relevant considerations.

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the NIH eRA Commons.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Section IV.5., “Funding Restrictions.”

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

Human Subjects Protection:Federal regulations (45 CFR 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (“NIH Policy for Data and Safety Monitoring,” NIH Guide for Grants and Contracts, https://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (https://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Access to Research Data through the Freedom of Information Act:The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see https://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research” (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

Required Education on the Protection of Human Subject Participants:NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy:NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov/) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov// and view the Policy or other Resources and Tools, including the Authors' Manual.

Standards for Privacy of Individually Identifiable Health Information:The Department of Health and Human Services (HHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the HHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, Internet addresses (URLs) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

Healthy People 2010:The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.